CN1144603C - Electron introduction and transportation device and display method - Google Patents

Abstract

The invention provides an electronic lead-in and delivery device, which comprises a display (14) which can be only in an on state and an off state, and a method for operating the display (14). Preferably, the display (14) is an indicator light (e.g., a light emitting diode) having both a lit and unlit state or an audible alarm (e.g., a buzzer) having both a sounded and silent state. The device (10) counts and stores the number of events (e.g., patient initiated drug delivery or patient condition detection) that occur within a predetermined time period (e.g., the period during which the device is worn by the patient). The number of events is displayed in a manner that cycles the display (14) between on and off states according to a predetermined mechanism that associates an on/off cycle number with the number of events. The present device and method allow for the use of simple and inexpensive means (e.g., LEDs) to display (e.g., to medical personnel) the number of events, such as the number of times a patient initiates drug delivery during a pre-treatment procedure.

Description

Electrotransport delivery device and display packing

The present invention relates to pass complete body surface,, carry medicine or medicament as skin with the electronics introductory technique.In more detail, the electronics that the present invention relates to have the cheap display of a series of event numbers that took place the course of treatment before the demonstration imports delivery device.

Recently, a lot of attention is drawn towards with the electronics importing and passes complete skin or tissue surface conveying medicine or medicament in patent and technical writing case studies." electronics importing " term that is used for herein is commonly referred to as, through as skin, the useful medicament of biomembrane conveying so mucous thin film or the fingernail (as, a kind of medicine) is arranged.Utilize electromotive force to cause or help this conveying.For example, use electronics to import a kind of useful healing potion is passed the blood circulation that skin is sent into human body.Electromigration (being also referred to as iontophoresis) relates to the conveying that electricity consumption causes charged ion as a kind of electronics importing process of extensive use.The electronics importing process electro-osmosis (electroosmosis) of another kind of type relates to and contain the liquid flow of wanting delivery of medicaments under effect of electric field.Also have another electronics importing process, promptly electroporation (electroporation) relates to the formation in the hole of of short duration existence on the biofilm under electric field action.Medicament or passively (as, do not have the electricity assistance) or on one's own initiative (as, under the influence of electromotive force) carry by the hole., in any given electronics importing process, more than these a kind of processes can take place simultaneously.Therefore, should provide the most generalized possible explanation to the term " electronics importing " that is used for herein, so that it comprises conveying that at least a medicament causes because of electricity or enhanced, perhaps, medicament is mixing of charged, uncharged or electrically charged and two kinds of neutrals, no matter the actual fed medicament adopts certain specific mechanism or number of mechanisms.

The electronics gatherer uses two electrodes at least, and they are with skin, fingernail, the electrical pickoff of certain part on other surface of mucous thin film, organ surface or health is arranged.An electrode is commonly referred to " alms giver " or " active " electrode, and medicament is that to be transported to body from this electrode intravital; Another electrode is called " opposed " or " returning " electrode, in order to constitute the closed circuit by health.For example, if the medicament positively charged that is transferred, as cation, anode just becomes active electrode or donor electrode so, and negative electrode is used to connect circuit.Perhaps, if medicament is electronegative, as anion, negative electrode is a donor electrode so.In addition, if conveying is cation and anionic medicament ion, or uncharged pharmaceutical dissolution, anode and negative electrode all can be considered to donor electrode so.

In addition, electronics importing induction system requires a storage will be input to the liquid solution of the medicament in the health or the liquid storage pool of suspension usually at least.The model of this alms giver's liquid storage pool comprises a pouch or cavity, mandruka or liner, and hydrophilic polymer or gel-type vehicle.For fixing or renewable one or more medicaments or drug source are provided, such alms giver's liquid storage pool is electrically connected to and places between male or female and the body surface.The electronics gatherer is also just like a joint or the such power supply of multiple batteries.Usually, a utmost point of power supply is electrically connected to donor electrode, and another utmost point is electrically connected to opposite electrode.In addition, some electronics gatherer has the electric controller of control through the electric current of electrode, thereby adjusts the speed of drug delivery.In addition, the binding agent, the insulated part that contact with body surface of passive flux control thin film, holding device, to reach impermeable part all be some other potential ingredient of electronics gatherer.

All electronics imports medicament delivery device and utilizes circuit to realize being electrically connected of power supply (as, battery) and electrode.In very simple device, disclosed as the United States Patent (USP) 4474570 of applications such as Ai Ruila (Ariura), this " circuit " only is an electric lead that is used to connect battery and electrode.The amplitude that other devices adopt various electronic components control power supplys to power to flow, polarity, regularly, waveform shape etc.See the United States Patent (USP) 5047007 of application such as Mc Nichol (McNichols).

So far, commercial transdermal (transdermal) electronics import delivery device (such as, by the road of outstanding his salt lake city, state (lomed) company " Phoresor " that sell not; " Du Bo injected system (the Dupel Iontophoresis System) " that sells than (Empi) company by the love rice of Sao Paulo, the Minnesota State (St.Paul); Especially Robert Webster seepage introducer 3600 (the Webster SweatInducer 3600) type sold of Wei Sike (Wescor) company of his state Luo Gaimu.) use a desktop power supply device and a pair of contact skin electrode usually.Donor electrode comprises drug solution, and opposite electrode comprises the solution with (bio-compatible) electrolytic salt of biocompatible.Should " satellite " electrode be connected to power supply device with the electric lead or the cable of long (as, 1-2 rice).Use the desktop power supply device of satellite electrode parts to examine the United States Patent (USP) 4141359 (seeing Fig. 3 and Fig. 4) of Benson applications such as (Jacobsen) the outstanding person; Draw United States Patent (USP) 5006108 (see figure 9)s of para ground (LaPrade) application; And hair is reined in middle disclosure of United States Patent (USP) 5254081 (seeing Fig. 1 and Fig. 2) of applications such as (Maurer).

Recently, proposed the working time longer, tie up on skin, little, self-contained electrotransport delivery device.The electronic component that the electronics of such cover miniaturization imports delivery device is miniaturization considerably also, or the form of integrated circuit (as microchip) or little printed circuit form.Electronic component, as amplitude by being electrically connected the electric current that forms the supply of control power supply such as battery, resistance, pulse generator, electric capacity, polarity, regularly, the circuit of waveform shape (with other parameter).So little, self-contained electrotransport delivery device is disclosed, for example, and at the United States Patent (USP) 5224927 of safe ripple (Tapper) application; The United States Patent (USP) 5203768 of application such as Hai Ke (Haak); The United States Patent (USP) 5224928 of applications such as Pori, west (Sibalis); In the United States Patent (USP) 5246418 of application such as extra large Nice (Haynes).

When allow patient's decision, and medicine transportation pump how frequent, own drug administration well known and come into operation.Such device is used in particular for using the Drug therapy pain that relieves the pain.Antalgica, as alleviate or the medicine of eliminate pain or medicament are usually used in removing as postoperative pain or the pain with the long-term pain of certain related to cancer.Particularly about postoperative pain, in the using of antalgica, meet difficulty.Use analgesic to reach calming down of desirable pain or eliminate because of difficulty is inexcessive (or the amount of owing).The difficulty of suitably using antalgica derives from various factors.Thereby the reaction between the other medicines that patient's age, liver function, renal function and the antalgica of using and patient take all can influence the pharmacokinetics of antalgica and influence the demand of patient to such antalgica.Because there are differences aspect the effective dose of treatment between patient and the patient, even a certain patient still continues to suffer misery behind the antalgica of having used routine dose.In addition, habit-forming or patient may suffer serious side effects (as, respiratory failure) to analgesic owing to worry may to make patient by excessive use, and doctor and nursing shortage amount are write a prescription and the narcotic-based painkillers of using in shortage have become a kind of trend.

Recently, the suitable attention that allowed the device of dosage of the analgesic that patient accepts preestablished limit inner control patient and system attractive.Common experience is that the administration that the patient that uses analgesic controls analgesic causes patient's antalgica dosage to be less than the desired dosage of doctor formula.The oneself of antalgica uses or the oneself of patient control uses and is called (and being incorporated in this) patient by the people and controls antalgica (PCA).

Known PCA device generally is the electromechanical pumps that needs the high capacity electrical power, as, the huge unit of alternating current power supply or a plurality of high capacity cells.Because theirs is huge and complicated, this commercial device requires with patient's restriction in bed usually, or the place of some basic fixed.

The PCA device is to carry medicine with vein or the subcutaneous mode that conduit or catheter are set.Must such structure be inserted in the vascular of choosing in advance or cell tissue by qualified medical worker.This specification requirement breaks through skin barrier, and this will have the danger of the infection of producing.(seeing United States Patent (USP) 5232448) by the Zdeb application.Therefore, when using commercially available PCA device, PCA requires experienced medical worker beginning on the scene and monitors the operation of PCA device, and incident is infected risk.In addition, (as, venous or subcutaneous) enters because percutaneous, makes commercially available PCA device be used for some misery.

Described in this patent documentation, be the conveying that the input analgesic helps by passive diffusion and electricity, the skin (trandermal) that sees through of the narcotic-based painkillers as fentanyl (fentanyl) is carried.See the United States Patent (USP) 4588580 of application such as Gai Er (Gale), and carry Wei Si (Teeuwes) and wait the United States Patent (USP) of applying for 5232438.S. Tai Siman (S.Thysman) etc. has described in technical literature and has seen through skin with electronics introductory technique (especially iontophoresis) and carry fentanyl, see " international pharmacopedics magazine " (InternationalJournal of Pharmaceutics), 101 (1994) 105-113 " skin ionization that sees through of fentanyl penetrates therapy: carry an and mechanism analysis " literary composition.Tai Siman (Thysman) etc. compared the fentanyl in the glass drying oven see through skin ionization penetrate therapy carry fentanyl in (with the mouse skin of a Plexiglas's pipe) and the glass drying oven through otch passive through the skin conveying.Tai Siman (Thysman) etc. asserts fentanyl is seen through the response curve that the dermal administration iontophoresis has been improved pharmacokinetics.

V. Pu Ruite (V.Preat) etc. is also at " 96 international pharmacopedics magazine " (96International Journal of Pharmaceutics), described in 189-196 (1993) " seeing through skin time fentanyl (Sufentanil) iontophoresis carries " literary composition and fentanyl similarly the electronics of time fentanyl (Sufentanil) import and carry.

M. Arthur's cloth is thought (M.Ashburn) and is waited at " pain and symptom are handled magazine " (Journalof Pain and Sympton Management) the 7th and roll up first phase, 27-33,1992." electrophore that is used for the morphine of postoperative analgesia is carried " literary composition has been described with the morphine of conventional P CA device mode and has been carried the electrophore of the morphine that connects together to carry.Arthur's cloth think of (Ashburn) etc. asserts that the electrophore conveying of morphine has reduced the application of PCA traditional in the postoperative pain processing.Also see Ge Lafu (Gourlav) etc. " fentanyl sees through pharmacokinetics and the pharmacodynamics reaction of dermal administration in the treatment postoperative pain " " pain " (Pain), 1989; 37:193-202; And Sai Beier (Sebel) etc. " fentanyl and time fentanyl skin (trandermal) that sees through in human body absorbs ", " 32 European clinical pharmacy magazine " (32 Eur.J.Clin.Pharamacal) 529-531 (1987).

Medicament administration as analgesic is starved of the history that medical worker on the scene understands patient's medication.For example, in pain management, the information relevant with the quantity of (as, dosage history) analgesic that patient took in given previous processing time section is very important to next step the strategy that decision is used to handle patient's pain and other symptom.Concerning patient and medical professional, electronics imports the delivery device simplification in the use of patient's control, and this point also is very important.

The invention provides the electronics that to store and to show the previous incident that takes place in the therapeutic process and import delivery device and method.

A kind of cheapness, display accurate, all wieldy electronics importing delivery device concerning medical worker and patient have been the present invention further provides.

The electronics that the present invention further provides record and has been presented at the quantity of the drug dose that patient oneself uses in the predetermined previous time section imports delivery device and method, this record or be shown as the medical worker and be used for explaining and understand the state of an illness.Known the quantity of previous drug conveying incident, the medical worker just can easily determine (or check) such as the medicine total amount of having carried, stay the medication amount of not carrying in the liquid storage pool, the trend of drug conveying (as, increase or subtract) but and such derived quantity or the derived quantity of various other data relevant with patient's drug conveying curve.

The invention provides a kind of method and apparatus that how many incidents took place between the operating period patient worn (patient-worn) electrotransport delivery device that is presented at.Conveyer device has used the display that has out and close two states.This method comprises counting and stores event quantity during use.Predetermined mechanisms according to the enumeration correlation connection that makes ON/OFF cycle-index and storage shows stored count in display circulation mode between open and closed.Preferably, predetermined mechanisms makes each ON/OFF circulation of display relevant with incident between X and Y, and X and Y respectively are 0 to 100 integer.

The display that display is preferably cheap, as, one has the signal lights of bright or the two states that do not work or has sounding or the voice guard of noiseless two states.

The drug dose that the device that the incident that is counted can be to use electronics to import is carried.In addition, incident also can comprise the detected patient's of device state.Detected state and the state range of being scheduled to can be compared and the state that exceeds preset range is each time counted.A better implement example of the present invention, the incident of being counted are the dosage that manually actuated electronics imports drug administration.

By the detailed description and the accompanying drawings of following invention, these and other purpose of the present invention and advantage can become more obvious.

The accompanying drawing summary

Among the figure, each several part is marked by all cross reference numbers, wherein:

Fig. 1 is the perspective view that electronics of the present invention imports delivery device.

Fig. 2 is the exploded view of electronics gatherer of the present invention.

Fig. 3 is the flow chart of an example of the device operation logic shown in the key diagram 2.

Fig. 4 is the flow chart of another example of the device operation logic shown in the key diagram 2.

Embodiments of the invention

Generally speaking, in predetermined therapeutic process, patient uses electronics gatherer of the present invention can carry any medicine substantially.Specific and the better implement example of incident and therapeutic process is the conveying of pain management medicine (as analgesic).By the switch that starts the electronics gatherer that closes, patient just can own drug administration.In case start, device is carried medicine by the electronics lead-in mode in predetermined interval.Therefore, in this embodiment of the present invention, this incident is automatically to carry predetermined drug dose on the basis that device starts.The length of delivery interval changes according to certain drug, the size that applies electric current, device size and specific therapeutic process to be carried.After delivery interval finished, the device automatic disconnection was also waited for starting and is carried another agent medicine.If patient needs more medicine, as, if patient still continues feels pain after delivery interval finishes, the starting switch that can close once more, device is placed in the drug conveying mode in the predetermined delivery interval of another section.On the other hand, if drug conveying at interval after, patient has been alleviated pain to a great extent, device is closed automatically and is waited for that patient restarts it when pain occurs next time.Therefore, patient can be according to him or she to tolerance degree (in the confirmable limit) titration of medicines of pain to reach required pain relieving degree, that is, patient does not have uncomfortable sensation.Device is designed to can be in predetermined treatment cycle, as 24 hours, tie up on patient skin (as, upper arm, underarm or chest).According to indication, the doctor place can be untied or return to device.

According to the present invention, this device has a display, take sound and light alarm form, have only the switch two states.The example of this display comprise generally be cheap, therefore and be applicable to simple signal lights, LED and the buzzer of complete disposable electronics gatherer.

Electronics gatherer of the present invention also comprises an electronic counter and storage device, is used to count and store the number of times of incident, and for example device starts the number of times of carrying medicine.Therefore, enumerator and storage device are connected to starting switch effectively so that switch closes and installs startup each time, and enumerator just adds 1.

Be the counting (starting the number of times of carrying a medicine as device) that shows storage, display also is connected to enumerator and storage device effectively.According to making ON/OFF cycle-index and the counting predetermined mechanisms that is mutually related, show counting by circulation mode display between open and closed.Preferably, predetermined mechanisms makes each ON/OFF circulation of display and the incident between X and Y (for example, all dosage is associated, and X, Y respectively are 0 to 100 integer, and 1 to 20 integer is better, preferably 1 to 10 integer.In this method, according to the predetermined mechanisms display open and closed (as, by the flicker of signal lights or the sounding of voice guard) between the circulation, come show dose history (as the number of times of patient's administration) by this way, be approximation at least.Therefore, signal lights can be used for being presented at previous event number of times in the therapeutic process.

The present invention is not limited to any specific medicine.Or the electronics of any specific therapeutic process imports and carries, manually actuated electronics import drug conveying and more particularly the electronics of the analgesic of manually actuated pain management import aspect the conveying, apparatus and method of the present invention have special purposes.Fig. 1-4 has illustrated and has been applicable to each example of carrying narcotic-based painkillers to carry with the electronics importing of pain management according to patient's requirement.About Fig. 1, it has provided one and has had the starting switch 12 of press button form and the perspective view of the electronics gatherer 10 of the display 14 with light emitting diode (LED) form.In the following description, other the various structures with switch 12 and the operation of LED14 similarity method will be easy to understand for the personnel that know this professional technique.

Fig. 2 is the exploded view of second device 10 ' of the present invention.Device 10 ' among Fig. 2 is different from the device 10 among Fig. 1 aspect the position of LED14 '.In present embodiment of the present invention, LED14 ' is positioned at an end of device 10 ' near press button 12.Device 10 ' comprises a loam cake 16, circuit board component 18, lower cover 20, anode 22, negative electrode 24, anode liquid storage pool 26, a negative electrode liquid storage pool 28 and is fit to the binding agent 30 of skin.Loam cake 16 has and is used for device 10 ' is fixed on flank 15 on patient's the skin.But loam cake 16 preferably is made up of the elastomeric material of injection moulding (as, ethylethylene amyl acetate).Printed circuit board assembly 18 is made up of integrated circuit 19 and discrete component 40 and battery 32.Printed circuit board assembly 18 usefulness pillars (not marking among Fig. 2) are attached to through via hole 13a and 13b and cover 16, and the end heating/fusing of pillar is so that be fixed in loam cake 16 with circuit board component.Lower cover is attached to loam cake 16 with binding agent 30, and the upper surface 34 of binding agent 30 adheres to lower cover 20 and comprises the loam cake 16 of the bottom surface of flank 15.

What (partly) was shown below the circuit board assemblies 18 is button cell 32.The battery of other type also can be used to provide energy for installing 10 '.

Usually by battery 32, electronic circuit 19,40, electrode 22,24, and medicine/chemicals liquid storage pool 26,28, all these are integrated in the unit of the whole series device 10 '.The adhesive strip 42,42 ' of conduction is used in the output of circuit board assemblies (not shown among Fig. 2), links to each other with electrode 24,22 through the hole on the groove that forms on the lower cover 20 25,25 ' 23,23 '.Electrode 22 contacts with electric and contacts with top 44 ', the direct mechanicalness of 44 generations of medicine liquid storage pool 26,28 in turn with 24.The bottom 46 ' of medicine liquid storage pool 26,28,46 contacts with patient skin through the hole 29 ', 29 on the binding agent 30.

When pressing the button switch 12, in the delivery interval of predetermined length, for example about 10 minutes, the electronic circuit on the circuit board assemblies 18 carries DC current for electrode/liquid storage pool 22,26 and 24,28.Better, the confirmation that device uses LED14 ' to brighten and/or the audio signal sent from the device as " buzzer " carries the drug conveying of a vision and/or audio frequency to begin at interval to the user, or similar.In 10 minute cycle, electronics imports medicine was passed patient skin, and as arm, per 10 minute cycle is as independent dosage or drug conveying incident.Circuit on the circuit board assemblies 18 comprises an electronic component, as, the number of times of counting conveying incident and be stored to an enumerator of depositor.

Anode 22 preferably is made up of silver, and negative electrode preferably is made up of silver chloride.Two liquid storage pools 26 and 28 preferably are made up of polymeric hydrogel material (ploymer hydrogel).Electrode 22,24 and liquid storage pool 26,28 are by lower cover 20 bumping posts.The present invention is not limited to any specific medicine liquid storage pool and forms or electrode material, and the present invention has special purposes in the conveying of analgesic.A kind of particularly suitable analgesic is a fentanyl.The preferably hydrochlorate of fentanyl or citrate.Under the situation of fentanyl hydrochlorate, this anode liquid storage pool 26 is " alms giver " liquid storage pools and contains this fentanyl hydrochlorate that this negative electrode liquid storage pool then contains the electrolyte with biocompatible.

Electronic circuit on press button 12, the circuit board assemblies 18 and battery 32 are packaged between loam cake 16 and the lower cover 20.Loam cake 16 preferably is made up of rubber or elastic material.Lower cover 20 is preferably by being easy to form groove 25,25 ' and be easy to prune portal 23,23 ' plastics or resilient thin plate (as polyethylene) material and form.The device 10 ' that assembles should have a water resisting property (as, splashproof) and best waterproof.System's section is lower, is easy to adapt to health, thus, allows wearing position (wearing site) and near liberty affair it.Anode/fentanyl liquid storage pool 26 and negative electrode/salt liquid storage pool is positioned at the one side of device 10 ' and contact skin, and in order to prevent to be short-circuited in normal handling with in using, both are separated effectively.

Device 10 ' is with having last adhesive surface 34 and adhering to patient body surface (as, skin) with the surface cement 30 of Body contact face 36.Adhesive face 36 has guarantees the position of holding device 10 ' on health in normal user incident, and predetermined (as, 24 hours) wear the cycle characteristic that can remove after (wear period).Last adhesive surface 34 adhere to lower cover 20 and with all electrodes and all medicine liquid storage pools retaining in lower cover groove 25,25 and keep lower cover 20 to be attached to loam cake 16.

Press button 12 be positioned at device 10 ' above, see through clothes easily and start.At short notice, for example 3 seconds, carry medicine but connect, thereby make probability become minimum without heart starting drive 10 ' by twice press button 12 starting drive.

With a switch activated audible alarm, the beginning of expression drug conveying, at this moment this circuit provides the DC current of predetermined value to all electrodes/all liquid storage pools in predetermined delivery interval.The scope that imports used electric current under the situation of fentanyl at electronics that control has an intense pain is generally 10 to 5000mA, better 50 to 500mA, preferably 200 to 300mA.Import under the situation of fentanyl at the electronics that control has an intense pain, general 1 to 120 minute of delivery interval is better at 5 to 30 minutes, preferably about 10 minutes.LED14 ' remains on " opening " state with the indicating device 10 ' drug delivery mode that has the initiative in the overall process of delivery interval.Battery 32 will have enough capacity to guarantee in the cycle of wearing in whole predetermined (for example, 24 hours) with predetermined DC current values constantly to device 10 ' power supply.

In a preferred embodiment of the invention, small and exquisite, a light and cheap signal lights with Kai Heguan (bright and do not work) two states is used as display.In better implement example of the present invention, make display with LED.

According to predetermined mechanism, LED opens and closes the historical information that flicker can automatically show drug conveying.Just has the electrotransport delivery device of " opening " and " pass " dual mode, LED preferably has following characteristic: (1) only presented event counting is (for example when device is in " pass " mode, the dosage history) (2) are in bright state in order to represent ongoing drug conveying always during drug conveying.

Fig. 4 is the flow chart of the expression method of operation, when conveyer device be in " passs " state (as, be in the time that is not delivery interval), the flicker of opening and closing with LED automatically presented event is counted.The circuit of device between closed alms giver in patient position on one's body and opposite electrode.Operation illustrated in fig. 4 can start by manually pressing press button 12, or installs perception automatically by this and be placed on the patient skin and start.The first step (square frame 402 and 404) is some parameter of initialization, comprises that establishing variable K equals zero, and establishes the drug conveying counting then and equals K or zero.Carry counting be the drug conveying incident (as, this device is activated the number of times of carrying medicine) accumulative total.Because the K initial value is zero, the answer of problem is a "Yes" in the square frame 406, and up to pressing the button switch 12, the logic loops of square frame 406 and 408 flow charts just stops.In case press the button switch 12, the answer of problem is a "Yes" in the square frame 408, up to short time delay (as 3 seconds) end or up to pressing the button for the second time switch 12, whichsoever at first takes place, and the logic loops of square frame 410 and 412 flow charts all stops.If time-delay in 3 seconds finished before pressing the button switch 12 for the second time, the answer of problem becomes "Yes" in the square frame 410, and flowchart logic is returned square frame 404.If it is opposite, for the second time pressed the button switch before time-delay in 3 seconds finishes, the answer of problem is a "Yes" in the square frame 412, the flowchart logic square frame 414,416 and 418 of flowing through, light LED14 and predetermined delivery interval (as, 10 minutes) in apply predetermined value to patient electronics import electric current.In case drug conveying stops at interval, the answer of problem becomes "Yes" in the square frame 418, and the flowchart logic square frame 420,422 and 424 of flowing through, these square frames are given and carried counting to add 1, extinguishes LED14 and stop to apply electronics to patient to import electric current.After square frame 424, flowchart logic is returned square frame 404.

Up to the predetermined short time (as, 3 seconds) the interior press button secondary that is pressed, LED just glimmers.In case patient presses the secondary press button in time-delay in 3 seconds, LED lights, and predetermined drug delivery mechanism begins.In case drug conveying stops at interval, carry counting to add 1, LED and drug conveying electric current are all closed.Herein (as, after drug conveying takes place for the first time), square frame 404 will be put K and equal to carry counting, as 1.K can be again less than 1 since then, and the answer of problem is a "No" in the square frame 406, and square frame 426 causes that LED dodges once, and afterwards, 428 K deduct 5 at square frame.Because K only equals 1 when beginning, after square frame 428, K equals one less than 1 number.This makes that the answer of problem becomes "Yes" in the square frame 406, flowchart logic in square frame 406 and 408 circulations till pressing the button switch 12 once more.

According to above-mentioned operator scheme, device import by electronics apply electric current and to drug conveying that patient carries medicine at interval in, LED is in illuminating state always.During not having electronics to import drug conveying, LED circulates always, with the drug conveying incident that provides indication to take place periodically (as, import the drug dose of using by electronics) the flicker LED of number of times shows.If there is not the flicker of LED, this means that patient is not activated any drug conveying incident.If patient has carried out the conveying incident one to five time, during " glimmering and show " continuously, LED glimmers once.If patient has carried out the drug conveying incident six times to ten times, at continuous scintillation duration, twice of LED flicker.If carried out ten once to 15 drug conveying incidents, at continuous scintillation duration, LED flicker three times, or the like.Therefore, in the predetermined mechanisms that makes LED ON/OFF circulation number of times and enumeration correlation connection, X equals 1, and Y etc. 5.

Preferably, between all demonstrations of continuously flicker, set up one section time-delay (seeing the square frame 430 among Fig. 4), make the medical worker be unlikely to show to produce between the time that the time that finishes and follow-up flicker demonstration begin and obscure in flicker for the first time.Time-delay (can arbitrarily be provided with as requested) about two to ten seconds or longer.

Select as the another kind that the drug conveying historical information automatically shows, this device also can be designed to the mode that medication history only answers patient or medical worker's requirement just to show and operate.As, in the short scheduled time (for example, 3 seconds) of discussing, only clicking press button 12 in the above, the historical information of medication just shows.It is overlapping so just to provide the function relevant with press button 12, and the electronic circuit that links to each other with switch 12 must be able to be distinguished, and is that patient requires drug conveying, or medical worker's query event enumerator and storage device.

See Fig. 3 now, it shows the operator scheme that medication history only answers patient or medical worker's requirement just to show.In this operator scheme, press (that is closure) press button 12 or beginning electronics and import drug conveying or begin counting (for example, medication history) demonstration.Similar to the flowchart logic of Fig. 4, the mechanism that the flow chart basis of Fig. 3 is scheduled to shows the medication historical information with the flicker of LED.Similar to Fig. 4 flow chart, one step of beginning is that some systematic parameter of initialization (square frame 302) comprises and Blip Counting (flag count) is set and K equals zero.Aftersquare frame 302, the logic of flow chart circulates up to pressing the button switch 12 insquare frame 304, causes that logic enterssquare frame 306.

If this device is not in drug conveying at interval at present, (that is, this device does not apply electronics to patient and imports electric current), three second subsequently cycle began.If for the second time do not press the button switch 12 in three second cycle, the answer of problem becomes "Yes" in thesquare frame 308, and flowchart logic enterssquare frame 310 beginning medication historical information records and shows.Because the initial value of K is zero, the answer of problem is a "Yes" in thesquare frame 312, does not cause the LED flicker, and flowchart logic is returnedsquare frame 304.

On the other hand, if before three seconds delay cycles finish, press the button switch 12 for the second time, the answer of problem becomes "Yes" in thesquare frame 314, flowchart logic is proceeded square frame 316,318 and 320, these square frames begin to apply electronics to patient and import electric current, begin drug conveying thus, light LED, the bidding note equals 1.In case predetermined drug conveying interval (as, 10 minutes) finish, the answer of problem just becomes "Yes" in thesquare frame 322, and flowchart logic is proceeded square frame 324,326 and 328, and these square frames add 1 to K, extinguish LED, and sign is set to zero again.Subsequently, flowchart logic is returnedsquare frame 304, waits for pressing the button switch 12.If press button 12 only is pressed once in 3 seconds delay cycle, logic enterssquare frame 310, therein, will carry count value to give K, and this moment, K equaled 1.Because K equals 1, the answer of problem is a "No" in thesquare frame 312, and flowchart logic continues to entersquare frame 330 and 332, and these square frames make the LED flicker once, and deduct 5 fromK.Square frame 332 makes the K value less than 1, and this makes that again the answer of problem becomes "Yes" in thesquare frame 312, and logic is returnedsquare frame 304, and circulates therein up to pressing the button switch 12 again.

Go through as above-mentioned, display comprises the LED according to the predetermined mechanisms flicker.Whenever the drug conveying incident has taken place one to five time, LED just glimmers once.If when the medication history display begins, patient does not begin the drug conveying incident as yet, and then LED does not glimmer.If patient has carried out the drug conveying incident one to five time, LED will glimmer once.If patient has begun drug conveying six to ten times, the LED secondary that will glimmer.Therefore, LED glimmers each time and means that patient has started the drug conveying incident, increased a predetermined number (as, can reach 5 times).Selected flicker number of times and the drug conveying of making counted the special predetermined number X and the Y of associated, can change according to conveying certain drug and the particularly desired value of the basis drug conveying incident that patient starts most probably in the cycle of wearing (wearing period), these technical ability will be understood those people that know this professional technique.

The flicker of LED or lighted or extinguished by LED by LED and finish, this initial state that depends on LED are not work or bright, and this understands those people that know this professional technique.Therefore, if carrying medicine when this device, and when LED is in bright state thus, the request of proposition medication historical information, the flicker of LED is finished by extinguishing LED periodically.On the other hand, be in closed condition if work as device, and LED is in when not working state thus, proposes the request of medication historical information, the flicker of LED is finished by lighting LED periodically.

In addition, flicker LED can with according to and the above-mentioned buzzer (beeper) that sends beeping sound about flicker LED similar mechanism replace.According to the traditional circuit design principle, the logic flow of Fig. 3 and Fig. 4 can be joined in the electronic circuit of electronics gatherer.Except Fig. 3 and operator scheme illustrated in fig. 4, can also show historical or other count information of medication by comprising automatic display mode and the mode that manually starts display mode.For example, electronics gatherer 10 can be operated like this: the mode of operation that discloses among (1) and Fig. 4 is similar, in the period between at interval, automatically shows counting in drug conveying, and (2) drug conveying at interval in, press the button switch 12 and show counting.Better, this device has " being forbidden to enter " (" lock-out ") characteristic in drug conveying at interval, so that press the button switch 12 enabling countings when showing, can not cause (without heart) to start another drug conveying at interval.

Apparatus and method of the present invention can be used for counting and show other incident except that the drug conveying incident, and this is to understand easily for those people that know this professional technique.For example, device of the present invention can comprise or measure the time of wearing of this device disappearance or measure the suitable time set of the treatment time that disappears.In order to indicate hourage and/or the number of minutes that has passed, this device shows the time that has passed in the mode that shows that suitably circulates between on off state.Device of the present invention in addition can comprise instrument that detects patient status and the instrument that detected situation and the acceptable scope of being scheduled to are compared.If detected situation has exceeded preset range, the enumerator content adds 1, and the counting of Xian Shiing is pointed out the off-limits number of times of patient status to the medical worker subsequently.The index detected and patient status that compares by this way comprises respiratory frequency, blood sugar concentration, muscle incident (for example, contracture), tissue oxygen content, organizes carbon dioxide content, body temperature, heart rate, or the like.Pick off provides the detection signal that flows to comparator, and comparator compares the predetermined acceptable scope of this detection signal and signal.If signal exceeds preset range, comparator informs that enumerator adds 1 to counting.In this mode, rolling counters forward and storage patient status (for example, heart rate) exceed the number of times of predetermined tolerance interval.In order to inform the history of the detected situation of patient medical worker, enumerator or automatic the demonstration count or count with suitable inquiry mode demonstration.Known the number of times of the such incident that takes place in therapeutic process, the medical worker can adjust dosage and other parameter better, so that more effectively handle patient's treatment situation.

The present invention is not limited to any specific electronics gatherer or imports any certain drug of conveying with electronics, and the present invention has special effectiveness in the device that allows patient oneself drug administration.In this class device, the oneself uses analgesic and has represented an important aspect with pain management.Therefore, following Example has illustrated better implement example of the present invention.The present invention has than the wider application of special embodiment that hereinafter provides, and this understands easily for those professional and technical personnel that know electronics importing drug conveying.Embodiment provides just for the accessible advantage of the present invention of implementing is described better.

Embodiment

Fentanyl alms giver liquid storage pool is housed is electrically connected to silver anode, the opposed liquid storage pool that electrolyte is housed is electrically connected to silver/silver chloride negative electrode.By the viscose top of conduction, the output of electrode and electronic circuit board component keeps electrically contacting.

The surface area of each alms giver and opposed hydrogel liquid storage pool is about 2.75cm usually², sectional area is 0.15cm²Anode alms giver liquid storage pool is equipped with 1% to 2% fentanyl hydrochlorate, about 30% polymer and additive (this additive comprises for making the complete cross linked polymer of hydrogel), and prevent selectively that current from becoming estranged and increase the wetting agent of frame stability.Anode is that a slice laminates the native silver on the conductive viscose bar.Anodic surface area is approximately 2.30cm²

The opposed liquid storage pool of negative electrode be equipped with electrolyte (as, NaCI), can optionally add buffer agent (buffered), about 30% polymer and additive (this additive comprises for making the complete cross linked polymer of hydrogel), and for preventing of selecting for use current from becoming estranged increases the wetting agent of frame stability.

Negative electrode is a silver chloride thin slice that laminates on conductive adhesive tape.Cathodic surface area is approximately 2.30cm²

The fentanyl conveyer device is an independent application, and fully-integrated electronics gatherer is identical with the device 10 ' shown in Fig. 2 in fact.This device contains electronic circuit, i.e. printed circuit-board assembly, lid and hydrogel alms giver (donor) liquid storage pool of powder charge thing and the opposed liquid storage pool of loading electrolyte of machinery system.This device is controlled, is used the narcotic-based painkillers fentanyl as required with the fentanyl hydrochloride form by patient.Alms giver's liquid storage pool is anodic, and opposed liquid storage pool is a negative electrode.System has skin adhesive layer that adapt to, outer surface, can tie up at upper arm or chest in 24 hours.

Behind patient's starting drive, during 10 minutes drug conveying in, electronic circuit per hour allows six such delivery interval to electrode/liquid storage pool delivered constant DC current.Start button switch 12 is informed patient by signal video and/or audio frequency.

The double switch 12 that presses the button in 3 seconds, in 10 minutes delivery interval, battery-powered electronic circuit carries the DC current of 240mA to two hydrogel liquid storage pools that contact with patient skin from circuit board assemblies.In period between twice drug conveying interval (that is, when device is in " closing " mode), output current is zero.The nominal open-circuit voltage is that 3 volts coin type lithium battery is reasonable selection.After delivery interval was finished in ten minutes, this device was closed automatically, waited for that another time double-click press button 12 is to start drug conveying interval next time.

When this device is in " closing " mode (that is, when medicine is not carried in the electronics importing), be presented at the counting of the drug dose of carrying in 24 hour runtime of device (or other pre-determined period) automatically.By means of the circulation of LED between " opening " and " pass " (that is, bright and do not work) two states, this counting is that unit represent with 5 twice drug conveying between at interval.In the better implement example, the flicker of LED (or buzzer send beeping sound) is explained as follows: the beeping sound that does not have the flicker of LED and/or do not have buzzer to send mean since this device tie up patient on one's body since, also do not have the fentanyl delivery interval to start.LED glimmers and/or buzzer sends once toot sound and means and start thefentanyl delivery interval 1 to 5 time.LED flicker twice and/or buzzer send twice toot sound and mean and start the fentanyl delivery interval 6 to 10 times.LED flicker N down and/or buzzer send N toot sound and mean and start the inferior fentanyl delivery interval of 5N-4 to 5N.

Claims (32)

Translated fromChinese

1、一种显示在病人佩戴的电子导入输送装置(10)的使用期间发生了多少次事件的方法；所述装置具有一个电子计数器，一个存储装置和一个显示装置；所述显示装置具有开和关的状态；该方法包括通过电子计数器确定特定事件发生的次数，并在数据存储装置中存储该次数，其特征是：根据将所述事件次数转换为所述显示装置的开和关的循环的特定模式的预定机制，以显示器(14)在开和关状态间循环的方式显示所述次数。1. A method of displaying how many events have occurred during use of an electrontophoresis delivery device (10) worn by a patient; said device having an electronic counter, a storage device and a display device; said display device having on and state of off; the method comprises determining by means of an electronic counter the number of occurrences of a particular event and storing the number in a data storage means, characterized in that: according to the number of times of said event being converted into cycles of on and off of said display means A predetermined mechanism for a particular mode to show said number of times in such a way that the display (14) cycles between on and off states.2、根据权利要求1所述方法，其中数据存储装置中的次数被划分为某一大小的各个组，该大小的范围从X到Y，X和Y每一个为0至100的整数，对事件的每一组或部分组使所述显示器循环一次。2. The method according to claim 1, wherein the times in the data storage device are divided into groups of a certain size ranging from X to Y, where each of X and Y is an integer from 0 to 100, for the event Each group or subgroups of , cycles the display once.3、根据权利要求1所述方法，其中数据存储装置中的次数被划分为某一大小的各个组，该大小的范围从X到Y，X和Y每一个为1至20的整数，对事件的每一组或部分组使所述显示器循环一次。3. The method according to claim 1, wherein the times in the data storage device are divided into groups of a size ranging from X to Y, where X and Y are each integers from 1 to 20, and for events Each group or subgroups of , cycles the display once.4、根据权利要求2所述方法，其中显示器(14)的零次开/关循环跟没有发生事件相关联。4. The method of claim 2, wherein zero on/off cycles of the display (14) are associated with no occurrence of an event.5、根据权利要求1所述方法，其中该显示器(14)以切换指示器状态的方式显示一个计数，该显示器从由带有亮与不亮两种状态的指示灯、带有发声与无声两种状态的声音报警器、以及它们的组合组成的小组中选出。5. The method according to claim 1, wherein the display (14) displays a count by switching the state of the indicator, the display is composed of an indicator light with two states of on and off, two states of sound and silence. Select from a group consisting of audible alarms in various states, and combinations thereof.6、根据权利要求5所述方法，其中该显示器(14)切换一个发光二极的状态管。6. The method according to claim 5, wherein the display (14) switches a state tube of a light emitting diode.7、根据权利要求5所述方法，其中该显示器(14)使蜂鸣器发出报警声音。7. The method according to claim 5, wherein the display (14) makes a buzzer sound an alarm.8、根据权利要求1所述方法，其中该事件包含在输送间隔内通过电子导入输送药物。8. The method of claim 1, wherein the event comprises delivery of a drug by electron introduction within a delivery interval.9、根据权利要求8所述方法，其中该输送间隔短于使用周期。9. The method of claim 8, wherein the delivery interval is shorter than the use period.10、根据权利要求9所述方法，其中该使用周期可达24小时。10. The method of claim 9, wherein the use period is up to 24 hours.11、根据权利要求1所述方法，其中该事件包括由该装置(10)检测的病人状况。11. The method of claim 1, wherein the event comprises a patient condition detected by the device (10).12、根据权利要求11所述方法，其中包括检测和计数病人状况超出预定范围的次数。12. A method according to claim 11 which includes detecting and counting the number of times the patient's condition falls outside a predetermined range.13、根据权利要求1所述方法，其中该事件由人工启动。13. The method of claim 1, wherein the event is manually initiated.14、根据权利要求13所述方法，其中至少部分事件是由病人启动该装置(10)上的开关(12)而开始的。14. A method according to claim 13, wherein at least some of the events are initiated by the patient actuating a switch (12) on the device (10).15、根据权利要求1所述方法，其中，当事件正在发生时，该显示器(14)也予以显示。15. The method of claim 1, wherein the display (14) also displays when an event is occurring.16、根据权利要求1所述方法，其特征是在连续事件之间显示该计数。16. The method of claim 1 wherein the count is displayed between successive events.17、根据权利要求1所述方法，其特征是人工启动该显示器(14)。17. Method according to claim 1, characterized in that the display (14) is activated manually.18、病人佩戴的电子导入输送装置(10)，包括对使用期间发生事件次数进行计数的电子计数器(18)，具有开和关两种状态的显示装置，和存储发生次数的存储装置，其特征是：根据将所述事件次数转换为所述显示装置的开和关的循环的特定模式的预定机制，以显示器(14)在开和关状态间循环的方式显示所述次数。18. An electrotransport device (10) worn by a patient, comprising an electronic counter (18) for counting the number of occurrences of events during use, a display device with two states of on and off, and a storage device for storing the number of occurrences, its features YES: Displaying said number of events in such a way that the display (14) cycles between on and off states according to a predetermined mechanism that translates said number of events into a specific pattern of on and off cycling of said display means.19、根据权利要求18所述装置，其中数据存储装置中的次数被划分为某一大小的各个组，该大小的范围从X到Y，X和Y每一个为0至100的整数，对事件的每一组或部分组使所述显示器循环一次。19. The apparatus according to claim 18, wherein the number of times in the data storage means is divided into groups of a size ranging from X to Y, where X and Y are each integers from 0 to 100, and for events Each group or subgroups of , cycles the display once.20、根据权利要求18所述装置，其中数据存储装置中的次数被划分为某一大小的各个组，该大小的范围从X到Y，X和Y每一个为1至20的整数，对事件的每一组或部分组使所述显示器循环一次。20. Apparatus according to claim 18, wherein the number of times in the data storage means is divided into groups of a size ranging from X to Y, where X and Y are each an integer from 1 to 20, for the event Each group or subgroups of , cycles the display once.21、根据权利要求18所述装置，其中显示器(14)的零次开/关循环跟没有发生事件相关联。21. The apparatus of claim 18, wherein zero on/off cycles of the display (14) are associated with no occurrence of an event.22、根据权利要求18所述装置，其中该显示器(14)可从由带有亮和不亮两种状态的指示灯、带有发声与无声状态的声音报警器、以及它们的组合组成的小组中选出。22. The device according to claim 18, wherein the display (14) can be selected from a group consisting of an indicator light with two states of on and off, an audible alarm with sounding and silent states, and combinations thereof selected from.23、根据权利要求22所述装置，其中的指示信号灯带有一个发光二极管。23. The device according to claim 22, wherein the indicator light has a light emitting diode.24、根据权利要求22所述装置，其中的声音报警器包括一个蜂鸣器。24. The apparatus of claim 22, wherein the audible alarm comprises a buzzer.25、根据权利要求18所述装置，其中该事件包含在输送间隔内通过电子导入输送药物。25. The device of claim 18, wherein the event comprises delivery of a drug by electron introduction within a delivery interval.26、根据权利要求25所述装置，其中该输送间隔短于使用周期。26. The device of claim 25, wherein the delivery interval is shorter than the use period.27、根据权利要求25所述装置，其中该使用周期可达24小时。27. The device of claim 25, wherein the period of use is up to 24 hours.28、根据权利要求18所述装置，包括用以检测病人状况的传感器。28. The device according to claim 18, including a sensor for detecting the condition of the patient.29、根据权利要求28所述装置，其中的每次事件包括一次检测到的超出预定范围的病人状况。29. The apparatus of claim 28, wherein each event comprises a detected patient condition outside a predetermined range.30、根据权利要求18所述装置，其中包括用以开始一个事件的人工启动开关(12)。30. Apparatus according to claim 18, including a manual activation switch (12) for initiating an event.31、根据权利要求25所述装置，其中该药物是止痛药。31. The device of claim 25, wherein the drug is a pain reliever.32、根据权利要求1所述方法，包含使用一个用以存储该计数值的存储器(18)，其中该计数符合于该装置被启动的次数。32. The method of claim 1, comprising using a memory (18) for storing the count, wherein the count corresponds to the number of times the device has been activated.

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